MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA IM FREE TRIIODOTHYRONINE (FT3); RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE

Catalog Number	10995584
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states observed depressed atellica im ft3 results compared to alternate methods.Qc was acceptable and there were no errors associated with the results.Siemens is investigating.The interpretation of results section of the atellica im ft3 instructions for use (ifu) states: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
Event or Problem Description
The customer does not routinely run the free triiodothyronine (ft3) test on the atellica im, however, the customer observed results from two patient samples were depressed compared to testing on the advia centaur ft3 and an alternate method ft3 assay.The atellica im ft3 results were not reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed ft3 patient results.
Additional Manufacturer Narrative
Mdr 1219913-2023-00168 was filed on (b)(6) 2023 reporting that a customer from outside the united states observed depressed free triiodothyronine results on the atellica im compared to the advia centaur and an alternate method.Mdr 1219913-2023-00168 supplemental 1 was filed on (b)(6) 2023 and mdr 1219913-2023-00168 supplemental 2 was filed on (b)(6) 2023.Correction - mdr 1219913-2023-00168 supplemental 2 reported that the customer used serum gel tubes, however, the customer uses serum non-gel tubes.Additional information - october 23, 2023 the samples were not available to be sent to siemens for testing.Additional information was not provided by the customer, therefore, further evaluation is not possible.There have been no additional reports of depressed discordant results from this customer.In section h6, the investigation findings and investigation conclusion codes were updated.
Additional Manufacturer Narrative
Mdr 1219913-2023-00168 was filed on august 16, 2023 reporting that a customer from outside the united states observed depressed free triiodothyronine results on the atellica im compared to the advia centaur and an alternate method.Mdr 1219913-2023-00168 supplemental 1 was filed on september 13, 2023.September 14, 2023 ¿ additional information: the customer confirmed the sample type was a serum gel tube not plasma as previously reported.Siemens continues to investigate.
Additional Manufacturer Narrative
Mdr 1219913-2023-00168 was filed on august 16, 2023 reporting that a customer from outside the united states observed depressed free triiodothyronine results on the atellica im compared to the advia centaur and an alternate method.August 21, 2023 ¿ additional information: the customer confirmed the following information: the same patient draw for each sample was run on all three systems on the same day.The sample type was plasma.The samples are not available to be sent to siemens for further testing.Siemens continues to investigate.

• Brand Name: ATELLICA IM FREE TRIIODOTHYRONINE (FT3)
• Common Device Name: RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 333 coney steet; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 17556943
• Report Number: 1219913-2023-00168
• Device Sequence Number: 3640168
• Product Code: CDP
• UDI-Device Identifier: 00630414599083
• UDI-Public: 00630414599083
• Combination Product (Y/N): N
• PMA/510(K) Number: K991692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/09/2024
• Device Catalogue Number: 10995584
• Device Lot Number: 278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 09/14/2023; 10/23/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/13/2023; 10/09/2023; 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown